Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery

Официальное название

A Randomized Controlled Trial on the Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery Compared to Traditional Rehabilitation

Обзор

Stroke is one of the leading causes of long-term disability worldwide, and early rehabilitation is considered crucial for improving functional recovery. Traditional physiotherapy mainly focuses on mobility, strength, and general exercises, while task-oriented rehabilitation emphasizes practicing meaningful, goal-directed activities related to daily life. This randomized controlled trial aims to evaluate the efficacy of early task-oriented rehabilitation compared to traditional rehabilitation in acute stroke patients. Patients admitted with ischemic or hemorrhagic stroke within 48 hours will be randomly assigned to either a task-oriented rehabilitation program or conventional physiotherapy. Interventions will be delivered 3-4 times per week, 45-60 minutes per session, during hospitalization and continued in outpatient follow-up. The primary outcome will be functional independence assessed at 3 months. Secondary outcomes will include stroke severity, quality of life, and patient-reported outcomes. The findings are expected to provide evidence for improving rehabilitation strategies in Egypt.

Подробное описание

Stroke represents a major health problem worldwide and is associated with long-term disability, particularly motor dysfunction of the upper and lower limbs. Early initiation of rehabilitation is believed to enhance neuroplasticity, maximize recovery, and improve independence in daily living activities. While conventional physiotherapy focuses on stretching, balance training, and strengthening exercises, task-oriented rehabilitation emphasizes practicing functional, goal-directed tasks such as reaching for objects, buttoning shirts, sit-to-stand practice, walking, and stair climbing.

This study is a randomized controlled trial including 148-158 patients with acute ischemic or hemorrhagic stroke admitted to Assiut University Hospitals within 48 hours of onset. Participants will be randomly assigned to either the experimental group (early task-oriented rehabilitation) or the control group (traditional rehabilitation). Sessions will be delivered 3-4 times per week, each lasting 45-60 minutes, both during hospital stay and follow-up in outpatient clinics.

The primary outcome is functional recovery assessed by the Fugl-Meyer Assessment and Functional Independence Measure (FIM) at 3 months. Secondary outcomes include NIH Stroke Scale, Modified Rankin Scale, Stroke Impact Scale, depression scores, and quality of life measures.

This trial is expected to provide high-quality local evidence regarding the benefits of task-oriented rehabilitation in the acute phase of stroke recovery, which may inform clinical practice and guide rehabilitation protocols in Egypt.

Вмешательства

• Поведенческое Task-Oriented Rehabilitation
  A structured program of repetitive, purposeful practice of everyday functional tasks (see Arm description). Delivered by trained physiotherapists 3-4 times/week, 45-60 min/session. Assigned Arm(s): Experimental: Task-Oriented Rehabilitation.
• Поведенческое Traditional Physiotherapy Rehabilitation
  Standard physiotherapy focusing on stretching, strength activation, balance and functional mobility exercises. Delivered 3-4 times/week, 45-60 min/session. Assigned Arm(s): Active Comparator: Traditional Physiotherapy Rehabilitation.

Первичные конечные точки

• Fugl-Meyer Assessment (FMA, Motor Domain) [Срок оценки: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge]

Вторичные конечные точки (2)

• Stroke Impact Scale (SIS) [Срок оценки: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge]
• Modified Rankin Scale (mRS) [Срок оценки: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge]

Критерии участия

Критерии включения

• Acute ischemic or hemorrhagic stroke diagnosed clinically and confirmed by imaging.
• Admission to hospital or referral to outpatient clinic within 48 hours after stroke onset.
• Age ≥ 18 years.
• Both sexes.
• Medically stable and fit for rehabilitation.

Критерии исключения

• Severe stroke not suitable for rehabilitation.
• Severe comorbidities (e.g., vital organ failure, malignancy).
• Severe aphasia, or severe visual or auditory impairment interfering with training.
• Severe upper limb spasticity (Modified Ashworth Scale > 3).
• Cognitive dysfunction (MMSE < 24 for educated; < 17 for illiterate patients).
• Stroke mimics (e.g., seizures, brain tumor, CNS infection, demyelinating diseases, hypoglycemia).
• Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Cen SY, Azen SP; Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276. PMID 26864411
• French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3. PMID 27841442
• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stro PMID 27145936
• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PMID 21571152
• Page SJ, Gater DR, Bach-Y-Rita P. Reconsidering the motor recovery plateau in stroke rehabilitation. Arch Phys Med Rehabil. 2004 Aug;85(8):1377-81. doi: 10.1016/j.apmr.2003.12.031. PMID 15295770

Идентификаторы

NCT: NCT07311304 · Task-Oriented Rehabilitation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗